MAUDE Adverse Event Report: SYNTHES ELMIRA 2.0MM DRILL BIT/QC/125MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.21
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient id # (b)(6).(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.The drill bit broke intraop and the broken portion was left in the patient which is non-implant grade.Device history records review was conducted.The report indicates that the: date of manufacture: 18 may 2017.Manufacturing location: elmira, new york.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h369027 of 2.0mm drill bits was processed through the normal manufacturing and inspection operations with no scrap, rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The device history record shows component lot h350165 of drill blanks was processed through the normal manufacturing and inspection operations with no scrap, rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h137037 met all specifications with no issues documented that would contribute to this complaint condition appropriate.
Event or Problem Description
It was reported that a distal tip of a drill bit broke into 2 pieces during a procedure on (b)(6) while attempting to create a hole for a 2.7mm cortex screw.The surgeon drilled through both cortices of the proximal ulna at approximately a twenty degree angle to the joint surface.Upon removing the drill bit, it was discovered that the tip had broken off into the patient's proximal ulna in the metaphyseal region.Fragments were generated from the broken device and were not recovered.No additional medical intervention required.The procedure was completed successfully with another drill bit readily available.Additional fluoroscopy time was required after the surgery to ensure satisfactory results, however there was no surgical delay during the procedure.The procedure was completed successfully with the patient in acceptable condition.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 2.0MM DRILL BIT/QC/125MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6991914
• Report Number: 3003506883-2017-10252
• Device Sequence Number: 1117430
• Product Code: HWE
• UDI-Device Identifier: 10886982186188
• UDI-Public: (01)10886982186188(10)H369027
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 310.21
• Device Lot Number: H369027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 68